A psychiatrist by training, Dr. Bill Carson has a wealth of knowledge around regulatory compliance and working through FDA approvals having successfully brought a number of mainstream drugs to market, including Abilify, which returned multiple billions of dollars for the six months gained at the end of the Abilify patent for obtaining pediatric exclusivity. Also under his leadership Otsuka was able to launch the Abilify follow-on, Rexulti, Jynarque for polycystic kidney disease, and ultimately the first FDA-approved digital medicine, Abilify MyCite.
Here he shares what he’s learned along the way about the complexities of regulatory testing and approvals, and what every healthcare startup executive should plan for.
Think of your product as frozen in time
Identify your most ideal target profile and label
Be prepared to break tradition
Do things by design, not default
Understand the importance of regulatory authority
Every month we’ll share Pioneer Spotlights where we sit down with our network of accomplished industry veterans on what they’ve learned and advice for startup founders. We look forward to showcasing more of our ecosystem with you.